The Impact of Implementing NIDCAP on Preterm Infants in the NICU
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|ClinicalTrials.gov Identifier: NCT00179933|
Recruitment Status : Terminated (Unable to fulfill intention of study, lost investigators.)
First Posted : September 16, 2005
Last Update Posted : October 11, 2010
|Condition or disease||Intervention/treatment||Phase|
|Infant, Premature||Behavioral: Newborn Individualized Assessment Program||Not Applicable|
Therapies that have brought about sharp decreases in neonatal mortality have not brought about similar decreases in neurodevelopmental morbidity for preterm infants. Developmentally supportive care is NICU care that seeks to optimize the developmental course and outcomes for preterm infants. While other staff training programs for developmentally supportive care exist, it is the Newborn Developmental Care and Assessment Program (NIDCAP) that has been the methodology used in randomly controlled trials that demonstrate positive medical and neurobehavioral outcomes for preterm infants receiving developmentally supportive care. NICUs that care for all out-born or transported infants face unique challenges in balancing developmentally supportive nursing care with the high-technological medical needs of the most critically ill and extremely premature infants. Yet it is these most fragile infants who can most benefit from the positive impact the NIDCAP program can offer. Yet, there are no published studies documenting the impact of the NIDCAP program on neurobehavioral outcomes of these transported preterm infants exclusively.
Objectives: The objective of this project is to study the impact of implementing the NIDCAP program of individualized patient consultation on the neurobehavioral organization of transported preterm infants in the NICU of a major pediatric medical center.
Research Methods: A random sample of approximately 40 preterm infants will be recruited to participate in this descriptive study. In this phase-lag design, 20 infants will participate in the pre-NIDCAP intervention phase and 20 infants will participate in the post-NIDCAP intervention phase. Each infant within each phase will be videotaped during 2 routine nurse-caregiving sessions. The first session will occur within 72 hours of admission to the NICU at Children's Memorial Hospital (CMH). The second session will occur when the infant is 34-36 weeks corrected gestational age. The videotapes will be collected so that observations of the infant's physical environment and caregiving and an assessment of the infant's behavioral function can be scored randomly at the end of the study by an outside consultant without bias as to what phase the infant participated. In addition, demographic data will be collected on the sample infants. Data will be subjected to descriptive statistics, inferential statistics and correlational procedures.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||40 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Impact of Implementing the Newborn Individualized Developmental Care and Assessment Program on Neurobehavioral Organization of Preterm Infants in the NICU|
|Study Start Date :||September 2005|
|Actual Study Completion Date :||February 2007|
- Behavioral function score within 72 hours of admission and Behavioral function score at 34-36 weeks gestation.
- Environment and caregiving score within 72 hours of admit
- Environment and caregiving score at 34-36 weeks gestation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00179933
|United States, Illinois|
|Neonatal Intensive Care Unit Children's Memorial Hospital|
|Chicago, Illinois, United States, 60614|
|Principal Investigator:||Barbara A Fleming, RNC, MS||Ann & Robert H Lurie Children's Hospital of Chicago|